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A Clinical Trial of Metformin in the Maintenance of Non-Hodgkin's Lymphoma Patients

Sponsor
Ruijin Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03600363
Collaborator
(none)
250
Enrollment
1
Location
2
Arms
39
Anticipated Duration (Months)
6.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is to evaluate the therapeutic effect of metformin as a maintenance therapy in high risk patients with complete remission of diffuse large B lymphoma / stage III follicular lymphoma after chemotherapy in the initial R-CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone, plus the monoclonal antibody rituximab) regimen

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
A Prospective Randomized Controlled Phase II Clinical Trial of Metformin in the Maintenance Therapy of High Risk Diffuse Large B Lymphoma / Stage III Follicular Lymphoma Patients With Complete Remission
Actual Study Start Date :
Sep 1, 2018
Anticipated Primary Completion Date :
Jan 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: metformin arm

Drug: Metformin
metformin (1.0g, bid) as a maintenance therapy in patients with complete remission
Placebo Comparator: control arm

Drug: Placebos
oral placebos as a maintenance therapy

Outcome Measures

Primary Outcome Measures

  1. Overall Survival [From date of randomization until the date of trail closed or date of death from any cause, whichever came first, up to 100 months]

Secondary Outcome Measures

  1. Progress Free Survival [From date of randomization until the date of trail closed or disease progressed, whichever came first, up to 100 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Male or female patient age >14 years old;

  2. Pathological types include: diffuse large B lymphoma, and stage III follicular lymphoma;

  3. At the initial stage of therapy, received standard R-CHOP regimen and complete remission after the first course of treatment;

  4. After complete remission, not consider to receive hematopoietic stem cell transplantation or chimeric antigen receptor T cell immunotherapy;

  5. Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) not exceed 2 times of the normal upper limit;

  6. Serum total bilirubin and creatinine not exceed 1.5 times of the normal upper limit;

  7. Serum creatinine not exceed 1.5mg/dl;

  8. Patients with high risk factors, including age > 60 year, or with diabetes/ impaired glucose tolerance, or with International Prognostic Index (IPI) score ≥2.

  9. Sign informed consent file.

Exclusion Criteria:

  1. Past medical history of high doses of cytarabine, methotrexate and rituximab maintenance therapy;

  2. Past medical history of any type of hematopoietic stem cell transplantation;

  3. Past medical history of lactic acidosis;

  4. Extreme weight loss failure, malnutrition or dehydration patients;

  5. Pregnant women or lactating women, or women who do not take contraceptive measures for childbearing age;

  6. Alopecia, mental retardation or psychiatric disorders that affect the patient's normal informed consent;

  7. Type 1.2 diabetes with ketoacidosis, liver function or renal insufficiency, pulmonary insufficiency, heart failure, acute myocardial infarction, severe infection and trauma, major surgery and clinical hypotension or hypoxia;

  8. Diabetes complicated with severe chronic complications (such as diabetic nephropathy, diabetic retinopathy);

  9. Any other serious complications occurred, depending on the outcome of the study;

  10. Before the intravenous pyelography or anterior angiography;

  11. Alcoholics;

  12. Deficiency of Vitamin B12, folic acid or iron.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ruijin Hospital Shanghai China

Sponsors and Collaborators

  • Ruijin Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhao Weili, Deputy Director of Hematology Department, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT03600363
Other Study ID Numbers:
  • RJ-NHL-1805
First Posted:
Jul 26, 2018
Last Update Posted:
Mar 11, 2020
Last Verified:
Mar 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Large B-Cell, Diffuse
Metformin

Study Results

No Results Posted as of Mar 11, 2020